NCT05929573

Brief Summary

Acute kidney injury (AKI), which can occur after major surgeries, leads to increased morbidity and mortality if not detected and managed promptly. In clinical practice, serum creatinine and urine output values of patients are monitored to detect AKI, but these parameters can cause delays in diagnosis. Additionally, studies have been conducted on biomarkers such as Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C in recent years, but definitive results have not been achieved. Renal Doppler Resistive Index (RDRI) is a non-invasive index believed to reflect renal vascular perfusion. RDRI measurement is a repeatable, inexpensive, and easy-to-apply technique. RDRI has been found to be associated with AKI in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. Furthermore, due to the impact on renal perfusion in patients undergoing major surgery, RDRI, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion. The aim of this study is to test the hypothesis, 'Does measuring postoperative RDRI in major abdominal surgery cases yield higher sensitivity and specificity values in detecting acute kidney injury compared to NGAL?'

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 25, 2023

Last Update Submit

July 29, 2024

Conditions

Keywords

Acute kidney injuryNeutrophil Gelatinase-Associated LipocalinRenal Doppler Resistive IndexMajor Abdominal Surgery

Outcome Measures

Primary Outcomes (2)

  • Plasma NGAL Level

    From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis

    Postoperative 4th hour

  • Renal Doppler Resistive Index

    Renal Doppler Resistive Index will be measured at the 4th hour after major abdominal surgery.

    Postoperative 4th hour

Interventions

Neutrophil Gelatinase-Associated Lipocalin, which can be measured from serum or urine, can detect acute kidney failure that may occur after surgery in the early stages.

Renal Doppler Resistive Index (RDRI) is a non-invasive index believed to reflect renal vascular perfusion. RDRI measurement is a repeatable, inexpensive, and easy-to-apply technique. RDRI has been found to be associated with AKI in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. Furthermore, due to the impact on renal perfusion in patients undergoing major surgery, RDRI, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo major abdominal surgery in Antalya Training and Research Hospital.

You may qualify if:

  • ASA I-III,
  • Patients undergoing elective major abdominal surgery

You may not qualify if:

  • Chronic kidney failure,
  • Using nephrotoxic drugs,
  • Patients with a history of kidney transplantation or nephrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (2)

  • Zeng X, McMahon GM, Brunelli SM, Bates DW, Waikar SS. Incidence, outcomes, and comparisons across definitions of AKI in hospitalized individuals. Clin J Am Soc Nephrol. 2014 Jan;9(1):12-20. doi: 10.2215/CJN.02730313. Epub 2013 Oct 31.

    PMID: 24178971BACKGROUND
  • Muthukrishnan K, Parida S, Barathi SD, Badhe AS, Mishra SK. Doppler resistive index to reflect risk of acute kidney injury after major abdominal surgery: A prospective observational trial. Indian J Anaesth. 2019 Jul;63(7):551-557. doi: 10.4103/ija.IJA_189_19.

    PMID: 31391618BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Erhan OZYURT, Assoc. Prof.

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

June 25, 2023

First Posted

July 3, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2023

Study Completion

July 20, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations